Methadone in Ambulatory Surgery

Overview

The μ-opioid receptor agonist methadone is frequently used in adult anesthesia and adult pain therapy. Methadone has an extremely long half-life, which confers therapeutic advantage by providing more stable plasma concentrations and long-lasting pain relief. Methadone perioperative pharmacokinetics and effectiveness in perioperative pain relief in inpatients is well characterized. There is, however, no information on methadone use in an ambulatory surgery setting and outpatient procedures. This pilot investigation will determine effectiveness of intraoperative methadone in reducing postoperative opioid consumption and providing improved pain relief in patients undergoing moderately painful, ambulatory surgical procedures.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 12, 2018

Interventions

  • Drug: methadone
    • Escalating dose of methadone up to .3mg/kg.
  • Drug: Control (Intra-operative administration of opioids, other than methadone)
    • Intra-operative administration of opioids, other than methadone

Arms, Groups and Cohorts

  • Active Comparator: Control
    • Control (Intra-operative administration of opioids, other than methadone)
  • Active Comparator: Treatment methadone 0.1 mg/kg
    • methadone 0.1 mg/kg
  • Active Comparator: Treatment methadone 0.15 mg/kg

Clinical Trial Outcome Measures

Primary Measures

  • Intraoperative Opioid Administration
    • Time Frame: Administered at induction of anesthesia
    • Data on opioids administered intraoperatively will be collected from the subject’s EMR.
  • Postoperative Opioid Administration
    • Time Frame: EMR reviewed at 24 hours post-administration or at hospital discharge
    • Data on opioids administered postoperatively will be collected from the subject’s EMR. Pain severity will be assessed using Numeric Rating Scale and colored-visual analogue scale. Pain relief postoperatively will be assessed using a 5 point scale [0-no relief, 4-complete relief]

Secondary Measures

  • Opioid Consumption Within First 30 Postoperative Days
    • Time Frame: 30 days
    • Daily opioid consumption for approx 30 days following surgery (from hospital discharge until postop clinic visit).
  • Pain Relief Within First 30 Postoperative Days
    • Time Frame: 30 days
    • Daily pain self-assessments using a numeric (0-10) rating scale were recorded in a home diary for approx 30 days following surgery (from hospital discharge until postop clinic visit). Zero was no pain and 10 was the worst possible pain. Patient’s 30-day post-discharge scores were averaged individually and compared in between groups. In addition, participants recorded pain interference with 7 activities of daily living – mood, ability to walk or move, sleep, normal work outside the home, normal work at home, recreational activities, and enjoyment of life on a 5-point Likert scale. Questions were based on the Patient-Reported Outcomes Measurement Information System Pain Behavior and Pain Interference item banks. Patients also recorded opioid and nonopioid analgesic use, sedation, and time to return to work.

Participating in This Clinical Trial

Inclusion Criteria

  • Age 18-65 years – Undergoing general anesthesia and moderately painful, ambulatory surgical procedures with anticipated overnight, postop hospital stay of < 24 hours – Signed, written, informed consent Exclusion Criteria:

  • History of or known liver or kidney disease. – Females who are pregnant or nursing. – Opioid tolerant patients (e.g. preoperative methadone therapy or use of fentanyl transdermal patches) – History of allergy to methadone

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Washington University School of Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Helga Komen, MD, Principal Investigator, Washington University School of Medicine

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